Biosimilar monoclonal antibodies – time for a regulatory rethink

Author(s): GaBI Journal Editor

The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies – are forcing regulatory authorities to reconsider what constitutes a biosimilar, writes Dr Ebbers and co-authors [1]. Many monoclonal antibodies (mAbs) will lose patent protection in […]

Read more →